Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU (PROMOREA1)

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: ICU-acquired Muscle Weakness

Treatments: Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02185989

ID RCB : 2014-A00566-41 (Other Identifier)

CHRO 2014-001

Details and patient eligibility

About

Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.

We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 yrs
• expected length of stay in the ICU higher than 72 hours
• motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview

Exclusion criteria

• Opposition expressed by the patient, his/her legal representative or a member of his/her family
• Pregnant woman
• Resuscitated cardiac arrest before inclusion
• Patient carrying a pacemaker or an implantable defibrillator
• Patient under extracorporeal membrane oxygenation
• Severe acute cerebral disease requiring deep sedation
• Brain death
• Guillain-Barré syndrome
• Myasthenia gravis
• Known Dementia than can affect the main endpoint assessment
• Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins
• Unstable traumatic injuries of the spine
• Severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days
• Amputation of a lower limb at the trans-metatarsal level or higher
• Inclusion in another interventional study with muscle strength assessment as the primary endpoint
• Moribund patient

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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314 participants in 2 patient groups

Electrical muscle stimulation and bicycling

Active Comparator group

Description:

Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization)

Treatment:

Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitation

Standard early passive/active rehabilitation

No Intervention group

Description:

In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses